The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02132520

Recruitment Status
:
Completed

First Posted
: May 7, 2014

Last Update Posted
: September 18, 2017

Sponsor:

University of Minnesota - Clinical and Translational Science Institute

Information provided by (Responsible Party):

University of Minnesota - Clinical and Translational Science Institute

The purpose of this study is to determine whether the combination of low frequency repetitive transcranial magnetic stimulation (rTMS) and motor-imagery-based brain computer interface (BCI) training is effective for enhancing motor recovery after stroke.

The PI's hypothesis is that, in comparison with traditional physical therapy alone, subjects receiving supplementary rTMS and BCI training will show greater functional improvements in hand motor ability over time as well as recovery of normal motor connectivity patterns.

Condition or disease

Intervention/treatment

HemiparesisStroke

Device: rTMSBehavioral: BCI Training

Detailed Description:

The goal of the present study is to develop and evaluate a brain based approach to improve motor recovery after stroke, by combining rTMS and BCI training. Treatments will consist of low frequency rTMS applied to the contralesional hemisphere, followed by BCI training to encourage activity within the lesioned hemisphere. The primary objective of this study is to test the main hypothesis above in a stroke patient population. Subjects will also undergo a period of BCI only treatments after completion of the combined rTMS and BCI portion.

Inter-hemispheric Inhibition will be evaluated using paired-pulse TMS both for the stroke hemisphere to non-stroke hemisphere direction as well as for the non-stroke hemisphere to the stroke hemisphere direction.

Subject Report of Symptoms [ Time Frame: within 12 weeks of participation ]

The subject report of symptoms assesses whether subject experience any adverse effects as a result of participation in the study.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years to 70 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

18-70 years of age

Cortical or subcortical stroke with isolated unilateral motor paresis

At least 3 months but no greater than 12 months post stroke and in stable conditions as judged by patient's physician

Impaired hand function compared to nonparetic side but at least 10 degrees of active finger extension

Able to ambulate at least 50 feet with minimal stand-by assistance

Upper Extremity Fugl Meyer (Fugl-Meyer et al., 1975) score of greater than or equal to 20 out of 66

Beck Depression Inventory (Beck et al., 1961) less than or equal to 19 out of 63

Mini-mental State Examination score (Folstein et al., 1975) greater than or equal to 24 out of 30

Must have an ipsilesional motor-evoked potential (MEP) in response to TMS

Must be stable outpatients currently undergoing rehabilitation consistent with the current standards of care

Must be able to communicate clearly in English

Must be able to provide consent in writing.

Exclusion Criteria:

Personal history of epilepsy or seizures within the past 2 years

Previous surgical procedure to the spinal cord

Any MRI incompatible devices

Pregnancy

Claustrophobia

Breathing disorder

Hearing problems or ringing in the ears

Bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient

Cognitive deficits, other non-motor neurological impairment, bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient